Daily Archives: September 20, 2021

CoImmune, Inc. to Participate in Oppenheimer Fall Healthcare Life Sciences & MedTech Summit

DURHAM, N.C., Sept. 20, 2021 (GLOBE NEWSWIRE) — CoImmune, Inc., a clinical stage immuno-oncology company working to redefine cancer treatment using best-in-class cellular immunotherapies, today announced that Charles Nicolette, chief executive officer of CoImmune, will present a corporate update on September 23, 2021 at 9:05AM EDT during the virtual Oppenheimer Fall Healthcare Life Sciences & MedTech Summit. Dr. Nicolette will review progress in development of the company’s allogeneic CAR-CIK technology platform for the treatment of liquid and solid tumors and will be available to participate in one-on-one meetings with investors during the conference being held September 21-23, 2021.

The following link can be accessed on September 23, 2021 at 9:05 AM EDT to watch the presentation live: https://wsw.com/webcast/oppenheimer16/clmm/2767483

A webcast of the presentation will also be available on the News page of the CoImmune website at https://www.coimmune.com/news/.

About CoImmune, Inc.
CoImmune is a privately held, clinical stage immuno-oncology company that will redefine cancer treatment using best-in-class cellular immunotherapies. Our allogeneic CAR-CIK technology platform for liquid and solid tumors is a variation on CAR-T therapy that promises enhanced efficacy with greatly reduced toxicity. Our autologous RNA-loaded dendritic cell technology for solid tumors uses amplified total tumor mRNA to program highly engineered dendritic cells to generate immune responses against neoantigens without the need to identify them. For more information visit www.coimmune.com

Investor Contact:
Lori Harrelson
Chief Financial Officer
CoImmune, Inc.
lharrelson@coimmune.com
919-287-6349

Media Contact:
Adam Daley
Berry & Company Public Relations
adaley@berrypr.com
212-253-8881

Kidoodle.TV® Levels Up Quantities of Kid-Friendly Gaming Content

The Safe Streaming™ service amasses huge gaming library of classic content and popular hits played by content creators

Kidoodle.TV

CALGARY, Alberta, Sept. 20, 2021 (GLOBE NEWSWIRE) — A Parent Media Co. Inc. (APMC) is excited to share that its flagship product, Kidoodle.TV®, has bolstered its library of gaming content in a major way during the global pandemic to keep up with viewer demand.

“It’s no secret the global gaming market is growing with more and more child-focused creators breaking. Noting this, we’ve aggressively added an extensive library of gaming content featuring some of the most popular games and gamers,” said Chief Content Officer Brenda Bisner.

Since 2020, the Kidoodle.TV service has increased its gaming library by close to 500%, adding additional episodes and new series focused on family-appropriate gaming. Working closely with kid-friendly gaming creators, Kidoodle.TV, brings the best series to audiences, allowing them to co-view together without fear of inappropriate language or violence being shown.

Families can now enjoy household-name classics such as Super Mario 64, Super Mario 3D World Bowser’s Fury, Legend of Zelda, Donkey Kong Country, Pokémon Sword & Shield, and Luigi’s Mansion being played by top-level creators on the Safe & Free™ streaming service.

“What makes us stand out is our quality assurance team who review hours upon hours of gaming content to ensure it’s safe for viewing by young, impressionable eyes,” said Bisner.

Kidoodle.TV also supports original content creators like AbdallahSmash who offers family-friendly walkthroughs and tutorials of overnight sensations, Animal Crossing and Pokémon Snap. Featured in Variety, AbdallahSmash notes that gaming can offer children an experience to build resilience. “Nobody is an expert at the beginning of trying something new — and that’s okay. When I play through video games, it’s inevitable that mistakes or sub-optimal plays are made and it’s how you learn from them that really matters. If you’re in a tough spot, I like to elaborate on how I can positively get myself out of it and overcome difficult challenges. Never giving up and pushing towards a positive resolution is the key to success that I strive to teach young viewers.” In addition to Abdallah Smash, other up-and-comer creators can be found on the service like Miss Charli, NEZLEY and LankyBox who offer widely popular Roblox content.

Access to 30,000+ programs and a continuously growing gaming library is completely free to watch on Connected TVs by searching for Kidoodle.TV or by downloading the app on a mobile device or tablet.

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About APMC and Kidoodle.TV®

Kidoodle.TV® is a family-focused Safe Streaming™ service committed to ensuring children have a safe alternative to stream their favorite TV shows and movies. Available in over 160 countries and territories on thousands of connected devices, Kidoodle.TV provides peace of mind with every show available on Kidoodle.TV strictly vetted by caring people committed to Safe and Free Streaming for Kids™. Kidoodle.TV is available on iOS, Android, Apple TV, Fire TV, LG, Samsung, VIDAA-enabled Hisense TVs, Chromecast, Roku, Vizio SmartCast, Amazon, Jio, Xfinity X1, Connected TVs, HTML5 Web, and many other streaming media devices. Kidoodle.TV is owned and operated by A Parent Media Co. Inc., a family-based company. Kidoodle.TV is certified by the kidSAFE® Seal Program and is the proud recipient of the Mom’s Choice Award®, a Stevie® Award, platinum winner of the Best Mobile App Award, and Parents’ Picks Award – Best Elementary Products. Visit www.kidoodle.tv to learn more. *Content availability varies by location.

Facebook: facebook.com/kidoodletv
Twitter: twitter.com/kidoodletv
Instagram: instagram.com/kidoodletv

Media Contact:
Contact | media@kidoodle.tv

Related Images

Image 1: Kidoodle.TV

Kidoodle.TV

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Ex-Goldman Sachs Partner Joins Crypto Unicorn Amber Group as CSO

Dimitrios Kavvathas

HONG KONG, Sept. 20, 2021 (GLOBE NEWSWIRE) — Amber Group recently announced the appointment of former Goldman Sachs Partner Dimitrios Kavvathas as the firm’s new Chief Strategy Officer.

In this new role, Dr. Kavvathas will work with Amber Group CEO Michael Wu and the senior leadership team to set the company’s strategic direction and execute its global growth strategy with an emphasis on the firm’s core business and licensing and regulatory efforts. Additionally, Dr. Kavvathas will help strengthen the company’s product and solution offerings and its aspiring leadership position in evolving decentralized markets.

“Dr. Kavvathas is an outstanding addition to the team, and he will have a significant influence on the organization’s success. With expertise in Asset Management, Cryptocurrencies, and Financial Derivatives, Dr. Kavvathas will ensure we continue to build upon the already strong momentum across Amber Group’s core businesses. In addition, Dr. Kavvathas’ ability to formulate and execute our initiatives will help optimize the firm’s complex organizational financial structure,” says Michael Wu, CEO of Amber Group.

Having earned a Ph.D. in Economics at the University of Chicago, Dr. Kavvathas is a highly accomplished business veteran with more than two decades of extensive leadership experience in global financial markets. Before joining Amber Group, Dr. Kavvathas spent 12 years at Goldman Sachs as a Managing Director and Partner in London before moving to Hong Kong in 2009 to co-head Asia Pacific Securities Division Distribution, where he also served, among others, on the Global Firmwide New Activities Committee and the Global Asset and Liability Committee, as well as the board of Goldman Sachs, Asia LLC. After retiring from Goldman Sachs in 2013, Dr. Kavvathas served as an adjunct professor at the University of Hong Kong, as well as VTB Capital’s Head of Global Markets, Asia Pacific, Noble Group’s s co-Head of Financial Services, and CIO of Harmony Advisors Ltd., a Hong Kong-based asset management firm. Most recently, Dr. Kavvathas co-founded and led Nomisma Holdings Pte. Ltd, a decentralized derivatives trading protocol powering regulated trading infrastructure, which is being integrated into Amber Group.

“I could not be more excited about the opportunity to work for the firm’s founding team, whose vision and amazing execution I was following with curiosity, intrigue, and increasing admiration from their very start. Amber Group aspires towards a leadership role in revolutionizing finance. I am humbled to play a role along this journey,” says Dr. Kavvathas.

About Amber Group

Amber Group is one of the world’s leading crypto finance service providers, operating 24/7 with a presence in Hong Kong, Taipei, Seoul, and Vancouver. To date, Amber Group has raised a total of $128 million in funding from China Renaissance Group, Tiger Global Management, DCM Ventures, Tiger Brokers, Sky9 Capital, Arena Holdings, Tru Arrow Partners, A&T Capital, Gobi Partners, Paradigm, Pantera Capital, Coinbase Ventures, Blockchain.com, Polychain Capital, Dragonfly Capital, and Fenbushi Capital. For more information, please visit www.ambergroup.io, or contact at contact@ambergroup.io.

Related Images

Image 1: Dimitrios Kavvathas

Chief Strategy Officer at Amber Group

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WillScot Mobile Mini Acquires Three Leading Regional Storage Services Companies

PHOENIX, Sept. 20, 2021 (GLOBE NEWSWIRE) — WillScot Mobile Mini Holdings Corp. (“WillScot Mobile Mini” or the “Company”) (Nasdaq: WSC), a North American leader in modular space and portable storage solutions, today announced that it closed the acquisitions of American Mobile Leasing, Inc., Equipe Container Services, Inc. d/b/a Moveable Container Storage (MCS), and Saf-T-Box, LP. The transactions were funded with cash on hand and borrowings under the Company’s revolving credit agreement. Combined, these acquisitions add about 11,000 storage units in the Company’s existing U.S. markets.

Brad Soultz, Chief Executive Officer, commented, “We are excited to welcome the employees of American Mobile Leasing, Equipe, and Saf-T-Box to the WillScot Mobile Mini family. Each company is a highly respected peer and strengthens our position in key markets across the United States. These acquisitions are consistent with our growth strategy, allowing us to extend our ‘Ready to Work’ value proposition to new customers and further expand our industry leading fleet availability and service capabilities. They also highlight the scalability of our technology platform, which allowed us to integrate seamlessly this morning and provided employees and customers access to our systems on day one post-closing. We will continue to make smart organic and inorganic investments in our business, while applying technology and our commercial and operational best practices to amplify returns. Again, welcome to our new team members. I look forward to their contributions as we collaborate together on the exciting opportunities ahead.”

Cautionary Statement Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and Section 21E of the Securities Exchange Act of 1934, as amended. The words “estimates,” “expects,” “anticipates,” “believes,” “forecasts,” “plans,” “intends,” “may,” “will,” “should,” “shall,” “outlook” and variations of these words and similar expressions identify forward-looking statements, which are generally not historical in nature. Certain of these forward-looking statements include statements relating value creation, the Company’s share price, and the Company’s future performance. Forward-looking statements are subject to a number of risks, uncertainties, assumptions and other important factors, many of which are outside our control, which could cause actual results or outcomes to differ materially from those discussed in the forward-looking statements. These risks include, without limitation, the risks and uncertainties described in the periodic reports we file with the SEC from time to time (including our Form 10-K/A for the year ended December 31, 2020), which are available through the SEC’s EDGAR system at www.sec.gov and on our website. Any forward-looking statement speaks only at the date which it is made, and WillScot Mobile Mini disclaims any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

About WillScot Mobile Mini Holdings Corp.

WillScot Mobile Mini Holdings trades on the Nasdaq stock exchange under the ticker symbol “WSC.” Headquartered in Phoenix, Arizona, the Company is a leading business services provider specializing in innovative flexible workspace and portable storage solutions. WillScot Mobile Mini services diverse end markets across all sectors of the economy from a network of approximately 270 branch locations and additional drop lots throughout the United States, Canada, Mexico, and the United Kingdom.

Contact Information

Investor Inquiries:

Nick Girardi

nick.girardi@willscotmobilemini.com

Media Inquiries:

Scott Junk

scott.junk@willscotmobilemini.com

Adagio Therapeutics Provides COVID-19 Antibody Program Updates as well as Business Highlights and Second Quarter 2021 Financial Results

New Data Supporting Potential of ADG20 for Both the Treatment and Prevention of COVID-19 to be Presented at IDWeek 2021

Patient Population in Global EVADE Phase 2/3 Clinical Trial of ADG20 Expanded following IDMC Assessment

$355.8 Million IPO Completed to Fund Continued Advancement of Portfolio of Antibody-based Solutions for Infectious Diseases with Pandemic Potential

WALTHAM, Mass., Sept. 20, 2021 (GLOBE NEWSWIRE) — Adagio Therapeutics, Inc., (Nasdaq: ADGI) a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of antibody-based solutions for infectious diseases with pandemic potential, today reported updates on its lead COVID-19 antibody program, ADG20, as well as recent business highlights and second quarter 2021 financial results.

“Across the globe, COVID-19 continues to be a significant health crisis affecting nearly every age group. With the continued emergence of new variants, broadly neutralizing therapies that can be used for both the treatment and prevention of the disease are critical to address the current endemic as well as potential future outbreaks,” said Tillman Gerngross, Ph.D., co-founder and chief executive officer of Adagio. “Our team is working closely with our global CRO partners on the execution of our ongoing global clinical trials of ADG20, STAMP and EVADE, while also preparing for the anticipated worldwide commercialization of ADG20, if approved.

“ADG20 is a highly differentiated antibody that we are advancing through pivotal trials for both the treatment and prevention of COVID-19. We are pleased by the recent assessment of unblinded data by the IDMC for the EVADE trial, and their support of our plans to expand enrollment to include adolescents and pregnant or nursing women,” said Lynn Connolly, M.D., Ph.D., chief medical officer of Adagio. “To date, we have generated a compelling data package for ADG20 that includes broad neutralization of the original SARS-CoV-2 virus and the known variants of concerns in in vitro models as well as a favorable pharmacokinetic and tolerability profile in our Phase 1 trial. Further, at this year’s IDWeek, we will release additional data from our Phase 1 trial as well as details regarding our dose selection process for treatment and prevention, which we believe further support the important role this novel antibody can play in combatting the ongoing pandemic.”

ADG20 COVID-19 Program Highlights

  • New ADG20 Data to be Presented in Multiple Posters during IDWeek: At the IDWeek 2021 Virtual Conference, Adagio plans to present additional data highlighting the potential for ADG20 to provide protection from COVID-19 for up to one year based on its extended half-life in humans combined with its broad and potent neutralizing ability demonstrated in laboratory testing. In addition, the data support the evaluation of a 300mg dose, delivered as a single intramuscular injection, in the ongoing Phase 2/3 STAMP (treatment) and EVADE (prevention) global clinical trials. The data will be presented in multiple posters, which will be available to registered attendees on the virtual platform throughout the duration of the conference, being held from September 29 – October 3, 2021. The presentations include:
    • 1086: A Whole-Body Quantitative System Pharmacology Physicologically-Based Pharmacokinetic (QSP/PBPK) Model that a priori Predicts Intramuscular (IM) Pharmacokinetics of ADG20: an Extended Half-life Monoclonal Antibody Being Developed for the Treatment and Prevention of Coronavirus Disease (COVID-19)
    • 633: Preliminary Results from a Phase 1 Single Ascending-Dose Study Assessing Safety, Serum Viral Neutralizing Antibody Titers (sVNA), and Pharmacokinetic (PK) Profile of ADG20: an Extended Half-Life Monoclonal Antibody Being Developed for the Treatment and Prevention of Coronavirus Disease (COVID-19)
    • 1089: Use of a Whole-Body Quantitative System Pharmacology Physiologically-Based Pharmacokinetic (QSP/PBPK) Model to Support Dose Selection of ADG20: an Extended Half-Life Monoclonal Antibody Being Developed for the Prevention of Coronavirus Disease (COVID-19)
    • 1088: A Whole-Body Quantitative System Pharmacology Physiologically-Based Pharmacokinetic (QSP/PBPK) Model to Support Dose Selection of ADG20: an Extended Half-Life Monoclonal Antibody Being Developed for the Treatment of Coronavirus Disease (COVID-19)
  • Patient Population Expanded in EVADE following IDMC Data Assessment: The independent data monitoring committee (IDMC) for the EVADE Phase 2/3 trial of ADG20 for the prevention of COVID-19 recently provided a recommendation to expand Phase 3 trial enrollment to include adolescents 12 years and older and pregnant or nursing women, as well as a decrease in the protocol-specified, in-clinic post injection monitoring time. The IDMC’s recommendations were based on their review of unblinded safety and tolerability data through the Day 28 post-treatment visit from 200 participants enrolled in the Phase 2 lead-in portion of the trial.
  • Partnership with Biocon Biologics Expands the Reach of a Potent and Broadly Neutralizing COVID-19 Antibody Treatment to Patients in India and Select Emerging Markets: In the second quarter of 2021, Adagio partnered with Biocon Biologics Ltd. to combat the ongoing COVID-19 crisis in southern Asia. The partnership provides Biocon rights to manufacture and commercialize an antibody therapy based on ADG20 in India and additional select emerging markets based on the commercial manufacturing process developed for ADG20. As part of the agreement, Biocon will be granted access to data from Adagio’s Phase 2/3 clinical trials as well as its anticipated Emergency Use Authorization package and other regulatory submissions to support approval or emergency authorization in India and other select emerging markets.

Recent Business Highlights

  • David Hering, Global COVID-19 Vaccine Expert, Appointed as Chief Operating Officer: Adagio recently appointed David Hering as the company’s chief operating officer. Mr. Hering joins Adagio from Pfizer, where he most recently served as the global mRNA business lead, a business specifically created to manage global COVID-19 efforts as well as future vaccines utilizing mRNA technology, and led the launch of the first-ever COVID-19 vaccine in the United States. Prior to his most recent role at Pfizer, Mr. Hering was president, North America at Pfizer, where he led a 700-person organization across a portfolio of vaccine products for COVID-19 and meningococcal and pneumococcal diseases.
  • $355.8 Million Initial Public Offering (IPO) Successfully Completed: In August 2021, Adagio sold 20,930,000 shares of common stock, including the full exercise of the underwriters’ option to purchase an additional 2,730,000 shares of common stock at a public offering price of $17.00 per share. The gross proceeds of the offering, before underwriting discounts and commissions and other offering expenses payable by Adagio, were approximately $355.8 million.
  • Collaboration with Scripps: Adagio entered into an exclusive research agreement with The Scripps Research Institute to identify broadly protective vaccine candidates for the prevention of influenza and beta coronaviruses.
  • Board of Directors Expanded with Industry Leaders to Support Future Growth: Adagio recently announced appointments of three industry veterans and area experts to its board of directors:
    • Tom Heyman, former president of the Johnson & Johnson Development Corporation (JJDC);
    • Anand Shah, M.D., former deputy commissioner for medical and scientific affairs at the U.S. Food and Drug Administration (FDA); and
    • Michael S. Wyzga, president of MSW Consulting, Inc. and former CFO of Genzyme

Second Quarter 2021 Financial Results

  • As of June 30, 2021, Adagio had cash, cash equivalents and marketable securities of $392.5 million, which includes net proceeds from its Series C financing completed in April. Pro forma cash, cash equivalents and marketable securities as of June 30, 2021 is $719.6 million after giving effect to our initial public offering which closed on August 10, 2021.
  • Research & development expenses including in-process research and development for the second quarter of 2021 were $37.6 million.
  • Selling, general & administrative expenses for the second quarter of 2021 were $7.1 million.
  • Net Loss for the second quarter was $44.7 million, or $0.18 per share.

About ADG20
ADG20, a monoclonal antibody targeting the spike protein of SARS-CoV-2 and related coronaviruses, is being developed for the prevention and treatment of COVID-19, the disease caused by SARS-CoV-2. ADG20 was designed and engineered to possess high potency and broad neutralization against SARS-CoV-2 and additional clade 1 sarbecoviruses, by targeting a highly conserved epitope in the receptor binding domain. ADG20 displays potent neutralizing activity against the original SARS-CoV-2 strain as well as all known variants of concern. ADG20 has the potential to impact viral replication and subsequent disease through multiple mechanisms of action, including direct blocking of viral entry into the host cell (neutralization) and elimination of infected host cells through Fc-mediated innate immune effector activity. ADG20 is administered by a single intramuscular injection, and was engineered to have a long half-life, with a goal of providing both rapid and durable protection. Adagio is advancing ADG20 through multiple clinical trials on a global basis.

About Adagio Therapeutics

Adagio (Nasdaq: ADGI) is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of antibody-based solutions for infectious diseases with pandemic potential. The company’s portfolio of antibodies has been optimized using Adimab’s industry-leading antibody engineering capabilities and is designed to provide patients and clinicians with a powerful combination of potency, breadth, durable protection (via half-life extension), manufacturability and affordability. Adagio’s portfolio of SARS-CoV-2 antibodies includes multiple, non-competing broadly neutralizing antibodies with distinct binding epitopes, led by ADG20. Adagio has secured manufacturing capacity for the production of ADG20 with third-party contract manufacturers through the completion of clinical trials and, if approved by regulatory authorities, through initial commercial launch. For more information, please visit www.adagiotx.com.

Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “anticipates,” “believes,” “expects,” “intends,” “projects,” and “future” or similar expressions are intended to identify forward-looking statements. Forward-looking statements include statements concerning, among other things, the timing, progress and results of our preclinical studies and clinical trials of ADG20, including the timing of our planned IND submissions, initiation and completion of studies or trials and related preparatory work, the period during which the results of the trials will become available and our research and development programs; our ability to obtain and maintain regulatory approvals for, our product candidates; our ability to identify patients with the diseases treated by our product candidates and to enroll these patients in our clinical trials; our manufacturing capabilities and strategy; and our ability to successfully commercialize our product candidates. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements and you should not place undue reliance on our forward-looking statements. These forward-looking statements involve risks and uncertainties that could cause our actual results to differ materially from the results described in or implied by the forward-looking statements, including, without limitation, those risks described under the heading “Risk Factors” in Adagio’s prospectus filed with the Securities and Exchange Commission (“SEC”) on August 6, 2021 and in Adagio’s future reports to be filed with the SEC, including Adagio’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2021. Such risks may be amplified by the impacts of the COVID-19 pandemic. Forward-looking statements contained in this press release are made as of this date, and Adagio undertakes no duty to update such information except as required under applicable law.

Contacts:

Media Contact:
Dan Budwick, 1AB
Dan@1abmedia.com

Investor Contact:
Monique Allaire, THRUST Strategic Communications
monique@thrustsc.com

ADAGIO THERAPEUTICS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(UNAUDITED)

(In thousands, except share and per share amounts)

June 30,
2021
December 31,
2020
Assets
Current assets:
Cash and cash equivalents(1) $ 392,509 $ 114,988
Prepaid expenses and other current assets 3,550 2,394
Total current assets 396,059 117,382
Deferred offering costs 1,933
Total assets $ 397,992 $ 117,382
Liabilities, Convertible Preferred Stock and Stockholders’ Deficit
Current liabilities:
Accounts payable $ 10,716 $ 8,153
Accrued expenses 27,181 4,919
Total current liabilities 37,897 13,072
Early-exercise liability 8 11
Total liabilities 37,905 13,083
Commitments and contingencies
Convertible preferred stock (Series A, B and C) $0.0001 par value; 16,944,484 shares authorized, issued and outstanding at June 30, 2021; 12,647,934 shares authorized, issued and outstanding at December 31, 2020; aggregate liquidation preference of $505,399 and $169,900 at June 30, 2021 and December 31, 2020, respectively 504,711 169,548
Stockholders’ deficit:
Common stock, $0.0001 par value; 150,000,000 shares authorized at June 30, 2021 and December 31, 2020; 5,599,240 shares issued and outstanding at June 30, 2021; 28,193,240 shares issued and 5,593,240 shares outstanding at December 31, 2020 1 1
Treasury stock, at cost; 0 shares and 22,600,000 shares at June 30, 2021 and December 31, 2020, respectively (85 )
Additional paid-in capital 4,067 154
Accumulated deficit (148,692 ) (65,319 )
Total stockholders’ deficit (144,624 ) (65,249 )
Total liabilities, convertible preferred stock and stockholders’ deficit $ 397,992 $ 117,382

(1)     Pro forma cash, cash equivalents and marketable securities as of June 30, 2021 is $719.6 million after giving effect to our issuance and sale of 20,930,000 shares of our common stock in our initial public offering at the price of $17.00 per share after deducting underwriting discounts, commissions and estimated offering costs which closed on August 10, 2021.

ADAGIO THERAPEUTICS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(UNAUDITED)

(In thousands, except share and per share amounts)

Three Months
Ended
June 30,
Six Months
Ended
June 30,
Period from
June 3, 2020
(Inception) to
June 30,
2021 2021 2020 (3)
Operating expenses:
Research and development(1) $ 35,067 $ 69,204 $ 48
Acquired in-process research and development(2) 2,500 3,500
Selling, general and administrative 7,124 10,695 50
Total operating expenses 44,691 83,399 98
Loss from operations (44,691 ) (83,399 ) (98 )
Other income (expense):
Interest income 23 32
Other expense (5 ) (6 )
Total other income (expense), net 18 26
Net loss and comprehensive loss $ (44,673 ) $ (83,373 ) $ (98 )
Net loss per share attributable to common stockholders, basic and
diluted
$ (0.18 ) $ (0.66 ) $
Weighted-average common shares outstanding, basic and diluted 249,769 125,574 21,250,000

(1)   Includes related-party amounts of $247 for the three months ended June 30, 2021, $435 for the six months ended June 30, 2021 and $0 for the period from June 3, 2020 (inception) to June 30, 2020.
(2)   Includes related-party amounts of $2,500 for the three months ended June 30, 2021, $3,500 for the six months ended June 30, 2021 and $0 for the period from June 3, 2020 (inception) to June 30, 2020.
(3)   The results for the period from June 3, 2020 (inception) to June 30, 2020 are the same for the three and six months ended June 30, 2020.

FDA Clears First Technology to Distinguish between Bacterial and Viral Infections Using the Body’s Immune Response – The MeMed BV® Test and MeMed Key® Platform

FDA Clears First Technology to Distinguish between Bacterial and Viral Infections Using the Body’s Immune Response The MeMed BV® Test and MeMed Key® Platform

  • MeMed BV is a first-of-its kind test that decodes the immune response to accurately distinguish between bacterial or viral infections within minutes
  • MeMed Key is a pioneering platform that enables rapid and sensitive measurements of multiple proteins at the point-of-need
  • The MeMed technology suite enables better informed antibiotic treatment decisions, an essential tool in the fight against the global threat of resistant bacteria

HAIFA, Israel, Boston, MA; September 20th, 2021 – MeMed, a leader in the emerging field of advanced host-response technologies, today announces that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for use of the MeMed BV® test on the point-of-need platform MeMed Key® to help healthcare providers distinguish between bacterial and viral infections. The technology has been cleared for both children and adults.

Bacterial and viral infections are often clinically indistinguishable, leading to the prescription of antibiotics for the treatment of viral infections, for which they are ineffective. Antibiotic misuse drives the emergence of antimicrobial resistance (AMR), one of the biggest healthcare challenges of our time.
The novelty of MeMed’s technology is that it decodes the body’s immune response to infection, the ‘host response’, rather than focusing on detecting the presence of a microbe. This allows robust diagnosis when the infection site is inaccessible or unknown, even when the pathogen is undetectable using conventional tests, or when the cause of infection are emerging new pathogens. It enables better informed antibiotic treatment decisions, an essential tool in the fight against resistant bacteria.

“For those of us who care for acutely ill children, we have been waiting decades for accurate, rapid diagnostics to confidently guide the care of moderately ill children without a clear focus of infection or recognizable viral illness. This novel test offers promise to help differentiate those children with self-limited viral illness from those with possible bacterial infection, thereby supporting the judicious use of antibiotics,” said Rich Bachur, MD, Professor of Pediatrics and Emergency Medicine, Harvard Medical School, and Chief, Division of Emergency Medicine, Boston Children’s Hospital.

“It has been a decade long journey to reach this point from concept to impacting patient lives,” said Dr. Eran Eden, MeMed’s co-founder and CEO. “This FDA clearance is a breakthrough moment in the field of advanced host-response and could not have been achieved without the dedication of the MeMed team, our clinical partners in the US and around the globe, and the support of the US Department of Defense and EU Commission.”

Sergey Motov, MD, Professor of Emergency Medicine, Maimonides Medical Center, New York, said“Host-response technologies are a new frontier in the management of patients with infectious diseases, with great potential to improve patient outcomes. Every day, I see adults with a complicated medical history presenting to the emergency room with a suspected respiratory tract infection. A technology like MeMed BV can significantly aid in their management.”

“We are now using MeMed BV in my department routinely to aid in determining whether a child with fever has a bacterial or viral infection. For example, we recently had a complicated case of a young child with fever but without a clear source. MeMed BV helped in early identification of a severe bacterial infection, that would otherwise be masked by viral PCR detection, lead to a change in the course of treatment, and made a big difference in the patient’s outcome,” said Dr Adi Klein, Director of the Pediatric Division, Hillel Yaffe Medical Center and Head of the Israeli Clinical Pediatric Society. “Introducing MeMed’s technology has had a significant impact on our medical practice, enabling us to be better stewards of antibiotics and improving patient outcomes.”

FDA clearance was based on a multi-center blinded clinical validation study enrolling over 1,000 children and adults and addresses goals laid out in the US National Action Plan for Combating Antibiotic Resistant Bacteria. The test provides highly accurate results with Area Under the Curve of 90% and 97% (primary and secondary endpoints). MeMed has established its US base in Boston and is ramping up commercial activities to ensure broad availability of its products across the US.

About MeMed
Our mission is to translate the immune system’s complex signals into simple insights that transform the way diseases are diagnosed and treated, profoundly benefiting patients and society. To learn more about MeMed and our solutions, please visit http://www.me-med.com

About MeMed BV®
MeMed BV® is a first-of-its-kind immune-based protein signature test, developed and validated over the course of decade-long collaborations with leading academic and commercial partners. It provides physicians with an indispensable tool to help distinguish between bacterial and viral infections across multiple pathogens, even if the infection site is inaccessible or unknown. MeMed BV® measures and computationally integrates the levels of three immune system proteins: TRAIL, IP-10 and CRP. When run on the MeMed Key® platform, MeMed BV® provides a result within 15 minutes. MeMed BV® has been independently validated on thousands of patients and the results have been published in leading peer-reviewed journals (including PediatricsThe Lancet ID,  PLOS OneBMJ Peds and European Journal of Clinical Microbiology & Infectious Diseases). The MeMed BV® test has received a CE Mark in Europe and AMAR clearance from the Israeli Ministry of Health.

About MeMed Key®
MeMed Key® is a pioneering technology platform, enabling highly sensitive measurements of multiple proteins, within minutes, at the point of need. It opens the way to quantification of a vast array of human proteins in healthy and disease states, where and when it actually matters. The MeMed Key® development program has been partially funded by the US Department of Defense and the EU Commission. MeMed Key® has received a CE Mark in Europe and AMAR clearance from the Israeli Ministry of Health.

MeMed Contacts:
Adee Mor, VP Marketing, MeMed
pr@me-med.com
Kfir Emmer, CFO, MeMed
kfir.emmer@me-med.com

Media relations contact:
Consilium Strategic Communications MeMed@consilium-comms.com

Please click here to see the full release in Hebrew

JEITO CAPITAL BECOMES A KEY PLAYER IN THE FINANCING OF LIFE SCIENCES IN EUROPE WITH THE CLOSING OF JEITO I AT €534 MILLION ($630 MILLION)

JEITO CAPITAL BECOMES A KEY PLAYER IN THE FINANCING
OF LIFE SCIENCES IN EUROPE WITH THE CLOSING OF JEITO I
AT €534 MILLION ($630 MILLION)

Jeito I exceeds target and becomes the largest European fund dedicated
to the life sciences sector

Jeito Capital is dedicated to working with biotech entrepreneurs to provide
financial and expert support in continuity to accelerate patients’ access
to groundbreaking therapies

Paris, September 20, 2021 – Jeito Capital, a rapidly growing, new, independent Private Equity firm dedicated to biotech and biopharma, today announced the final closing of its first fund, Jeito I, at €534 million ($630 million), exceeding its original target of €500 million. Jeito I is the largest European fund dedicated to supporting companies in the life sciences sector.

Jeito Capital is building a strong and diversified portfolio of biotech and biopharma companies primarily based in Europe with global reach, focused on the treatment of life-threatening diseases. Jeito’s unique investment model provides support to entrepreneurs by a multi-talented team of experts integrated in the investment team across the entire drug development value chain, from translational science to market access and commercialization, providing significant capital in continuity, up to €80 million ($100 million) in a single company.

Jeito I investments to date include French-based SparingVision and InnoSkel, in the fields of genomic ophthalmology and rare skeletal disorders, respectively, Dutch biotech Neogene Therapeutics in solid tumors, UK-based Pulmocide in severe respiratory diseases, and Swiss-French Alentis Therapeutics in fibrosis and related cancers.

Jeito I attracted leading global investors including the European Investment Fund (EIF), the American pension fund Teacher Retirement System of Texas (TRS), which has made its first-ever investment into a European fund dedicated to the biotech sector, and Temasek, a global investor headquartered in Singapore with deep experience investing in life sciences.

Founded and directed by Dr Rafaèle Tordjman, MD PhD, Jeito Capital was launched in January 2020 and completed a first funding round of €200 million with the strategic support of investors such as Aviva, AXA, the French public investment bank (BPI), BNP Paribas Fortis, the Caisse des Dépôts et des Consignations (CDC), CNP Assurances, Pro BTP, etc. In the following months Sanofi selected Jeito as its first ever investment into a private French-based fund, investing €50 million.

Rafaèle Tordjman, Founder and CEO of Jeito Capital, said: “We are extremely proud to have closed Jeito I, making it the largest European fund dedicated to the life sciences sector. We have thus exceeded our original target and have attracted a group of leading and diverse global investors, a testament to Jeito’s unique investment model and team. I am pleased to welcome new investors including the EIF, TRS and Temasek and would like to thank our existing investors for their unwavering support. This important achievement will enable Jeito to fulfill its mission: to provide continuous financial support and industry expertise to talented entrepreneurs to accelerate the development of revolutionary therapies and guaranteeing patients quicker access to medical innovations.”

Sabine Dandiguian, Managing Partner of Jeito Capital, added: “This exceptional fundraising success confirms Jeito’s investment model driven by Rafaèle Tordjman. I am very proud to have been part of this multi-talented team since the very beginning which, thanks to its expertise across all stages of company development, is able to uncover and support the best scientific quality startups in Europe, with a global reach. Thanks to Jeito’s dynamic and collaborative team we have already developed a pipeline of high-quality deal flow. We look forward to achieving our shared ambitions and making a significant and meaningful difference to patients’ lives.

Currency converter: €1 = USD$1.18 as of 14 September 2021

About Jeito Capital
Jeito Capital is a global leading investment company with a patient benefit driven approach that finances and accelerates the development and growth of ground-breaking medical innovation. Jeito empowers and supports entrepreneurs through its expert, integrated, multi-talented team and through the investment of significant capital to ensure the growth of companies, building market leaders in their respective therapeutic areas with accelerated patients’ access in Europe & the United States. Jeito Capital has €534 million under management. Jeito Capital is based in Paris with a presence in Europe and the United States. For more information, please visit www.jeito.life, or follow on Twitter @Jeito_life or LinkedIn.

For more information please contact:

Jeito Capital
Rafaèle Tordjman, Founder and CEO
contact@jeito.life

Assistant : Marine Beigneux
marine@jeito.life

Consilium Strategic Communications (international PR)
Mary-Jane Elliott / Melissa Gardiner / Davide Salvi/ Kris Lam
Jeito@consilium-comms.com

Tilder (French PR)

Marion Bougeard
m.bougeard@tilder.com

Tel: +33 6 35 36 35 00

Tel: +44 (0) 20 3709 5700

Tel: +33 (0) 6 76 73 57 31

 

Please click here to see the full release in French